DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Eye Institute
NATIONAL ADVISORY EYE COUNCIL
Minutes of Meeting
June 18, 2009
The National Advisory Eye Council (NAEC) convened for its one hundred twenty-second meeting at 8:30 am on Thursday, June 18, 2009, at The Melrose Hotel, 2430 Pennsylvania Avenue, NW, Washington, DC. Paul A. Sieving., M.D., Ph.D., the Director of the National Eye Institute (NEI), presided as Chair of the Council. The meeting was closed to the public from 8:30 am until 11:00 am for the review of grant and cooperative agreement applications, and for the review of the Board of Scientific Counselors Report, Section on Epithelial and Retinal Physiology and Disease. On Thursday June 18, 2009 from 12:03 pm until 4:15 pm, the meeting was open to the public.
COUNCIL MEMBERS PRESENT:
Dr. Joseph Bonanno
Dr. James Chodosh
Dr. Scott W. Cousins
Dr. (Col.) Donald A. Gagliano
Mr. Ronald J. Gardner
Dr. Charles D. Gilbert
Dr. Mae O. Gordon
Dr. Gunilla Haegerstrom-Portnoy
Dr. Mary C. McGahan
Ms. Alberta Orr
Dr. Val C. Sheffield
Dr. Richard A. Stone
Dr. Marco A. Zarbin
COUNCIL MEMBER ABSENT:
Dr. Juan I. Korenbrot
NEI STAFF PRESENT:
Dr. Neeraj Agarwal
Dr. Houmam Araj
Dr. Deborah Carper
Dr. Hemin R. Chin
Ms. Janet Craigie
Mr. Donald Everett
Dr. Richard Fisher
Ms. Jerusha Gittlen
Dr. Shefa Gordon
Ms. Jean Horrigan
Mr. J. Kevin Keating
Dr. Natalie Kurinij
Ms. Marilyn Laurie
Dr. Andrew P. Mariani
Dr. Loré Anne McNicol
Dr. Jennifer Mehren
Dr. Michael D. Oberdorfer
Dr. Samuel C. Rawlings
Dr. Maryann Redford
Dr. Merlyn Rodrigues
Dr. Grace L. Shen
Dr. Anne E. Schaffner
Dr. Paul A. Sieving
Dr. Michael A. Steinmetz
Dr. Jerome R. Wujek
OTHER NIH STAFF PRESENT:
Dr. Michael H. Chaitin, Center for Scientific Review (CSR)
Ms. Mary Frances Deutsch, Office of the NIH Director (OD)
Dr. George McKie, CSR
Dr. Jerry Taylor, CSR
MEMBERS OF THE GENERAL PUBLIC PRESENT AT THE OPEN SESSION:
Dr. Bobbie Austin, Association for Research in Vision and Ophthalmology (ARVO)
Ms. Rebecca Hyder, American Academy of Ophthalmology
Dr. Israel Goldberg, Health Research Associates
Thursday, June 18, 2009
CLOSED PORTION OF THE MEETING
The meeting was closed to the public at 8:30 a.m. in accordance with the determination that it was concerned with matters exempt from mandatory disclosure under Sections 552b(c)(4) and 552b(c)(6), Title 5, U.S. Code and Section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix2).
CONFIDENTIALITY / AVOIDANCE OF CONFLICT OF INTEREST
Dr. Andrew Mariani, Executive Secretary of the Council, reviewed policies and procedures regarding confidentiality and the avoidance of conflict of interest situations. To avoid conflict of interest, members of federal advisory committees must not participate in the discussion of any application or proposal in which they, their spouse, minor child, close professional associate, or organization has a financial interest or affiliation. The Council members signed a statement certifying that they were absent during such discussions.
Council members absented themselves from the meeting during discussion of and voting on applications from their own institutions, or other applications in which there was a potential conflict of interest, real or apparent. Members signed a statement to this effect.
REVIEW OF RESEARCH, RESEARCH TRAINING, AND COOPERATIVE AGREEMENT APPLICATIONS
REVIEW OF THE REVIEW OF BOARD OF SCIENTIFIC COUNSELORS REPORT, SECTION ON EPITHELIAL AND RETINAL PHYSIOLOGY AND DISEASE.
OPEN PORTION OF THE MEETING
INTRODUCTION AND DIRECTOR’S REPORT
Dr. Paul Sieving convened the open session of the 122nd National Advisory Eye Council (NAEC). He introduced and welcomed Col. Donald A. Gagliano, M.D., M.H.A., Executive Director of the Department of Defense/Department of Veterans Affairs Vision Center of Excellence. Dr. Gagliano is the newly-appointed Department of Defense ex officio member of the NAEC.
Dr. Sieving thanked the Council members who attended a congressional event celebrating the 40th anniversary of the NEI. The NEI 40th anniversary is being recognized on the NIH campus by a number of symposia and events. One recent event on vision rehabilitation featured the showing of BLINDSIGHT, the award winning documentary film. BLINDSIGHT features Erik Weihenmayer, a blind mountain climber who embarked on an extraordinary expedition up the north face of Mount Everest, with six blind Tibetan students. Prior to this journey, Erik worked with NEI-supported scientists in the development of BrainPort, an apparatus in which a head-mounted camera sends electronic signals to the tongue and then to the brain to provide a “visual field” for a visually impaired person. Using BrainPort, Erik was the first blind man to reach the summit of Mount Everest.
In April, a Symposium on Genetics and Genomics in Vision was held at NIH. This symposium examined current advances in genetics and genomics and their impact on vision science. The presentations included genetic screens of disease genes and modifiers, genetic discoveries and translational research, and genetic studies of myopia and strabismus. It brought together geneticists, biologists and clinician scientists to highlight current achievements and future promises of vision research. The symposium will foster ongoing collaborative efforts and will encourage new initiatives, both within and outside the NIH research community, to achieve a better understanding of the genetic and biological bases of eye diseases and the exploration of novel treatment strategies.
Dr. Sieving noted that a joint NEI/NIBIB Symposium on Advances in Optical Imaging was held on June 1 and 2. This symposium focused on high resolution imaging of complex biological systems and described advances at the theoretical, technical, and clinical levels that bridge technology, and, clinical diagnosis critical for ophthalmology and a growing number of medical fields. The challenges for the next generation of ocular imaging devices include improving the speed of image acquisition, developing better and faster software for processing ocular images, integrating multiple image modalities, and developing new methods to image function as well as structure. In addition, there was emphasis on multidisciplinary approaches to accelerate the translation of advanced technologies from the physical sciences and engineering into biomedical research.
Dr. Sieving discussed how the American Recovery and Reinvestment Act (ARRA) is being used to stimulate the economy of science and health with $174 million dollars allocated to the NEI. Approximately 30,000 Challenge Grants applications have been received and approximately 200 will be funded by the NIH OD and possibly another 500 to 600 will be funded by the IC’s. Looking forward at new opportunities for medical research, there is a draft bill dealing with the words cures, acceleration, and network. The “H” in NIH stands for health, a subject of major public interest with wide media coverage of health care reform that will continue to be discussed for the next several years. Research at NIH aims to understand disease mechanisms through research in order to improve the health of the American people. The National Advisory Eye Council has a role in determining how to balance basic and clinical research so that there will be an impact in treating visual disorders. Now that we understand disease pathways due to gene discovery, the creativity of our translational clinical and basic scientists will determine how to modify those pathways. The NEI Program Planning will help shape the concept we have of vision research. Now that we better understand particular diseases, the challenge is to take this knowledge to the next level of making a difference in eye health, and balance that against the need to find more genes and successful basic discoveries.
REPORT ON NEI WORKSHOP TO IDENTIFY GAPS, NEEDS, AND OPPORTUNITIES IN OPHTHALMIC GENETICS
Dr. Hemin Chin briefed Council on the workshop, held June 4 and 5, 2009 at the Airlie Center, Warrenton, VA. It was co-organized by DER (Division of Extramural Research) and OPPA (Office of Program Planning and Analysis) and Co-chaired by Drs. Janey L. Wiggs and Elaine R. Mardis. The purpose was to identify the scientific opportunities in ophthalmic genetics that will harness the power of new genetics methodologies and genomic technologies, to establish a list of goals to move ophthalmic genetics forward over the next decade and to propose strategies or initiatives to achieve them, considering the most effective use of limited NEI resources
Each group of participants was requested to present white papers that were shared and discussed. Recommendations were made for needs and opportunities in general as well as specifically for particular diseases. The general needs and opportunities were identified as genotype-phenotype database, phenotype-genotype centers, collection of ‘Super’ controls, NEI tissue/cell line/DNA Repository, identification of disease pathways, transcriptome and proteome analysis, ocular cell profiling, Centers for Animal Phenotypes, Bioinformatics/biostatistics Training Consortia, disease-based consortia (e.g., NEIGHBOR), and pharmacogenetic/pharmacogenomic adverse events.
The disease-specific needs and opportunities identified in the workshop were identification of modifier genes (retinal degeneration and RP); identification of risk factors (AMD, diabetic retinopathy, glaucoma, cornea, lens); development of risk assessment screens, and development and testing of novel therapies (AMD, identification of genes and risk factors for common forms of strabismus and myopia; identification of genes responsible for Mendelian forms of high myopia, and optic neuropathies and stem cells).
Council noted that resource centers are enormous, expensive, and may not really serve the vision community. Would it be wise to invest in these resource centers that are turning over every two to three years? Council suggested putting funding in bioinformatics and biostatistics and into training in bioinformatics and biostatistics, an initiative that could be readily implemented. Dr. McNicol and Dr. Chin indicated that plans for an NEI Funding Opportunity Announcement for training in Statistical Genetics and Bioinformatics were underway.
OVERVIEW OF NEI PROGRAM PLANNING
Dr. Richard Fisher, Director of the Office of program Planning and Analysis, gave an historical overview of Program Planning at the NEI from 1973 until the present. He said the objectives were to develop a living, working plan using an inclusive, transparent, and participatory process. Also, to identify priorities based on core principles of investigator-initiated research representing the main engine for scientific discovery and that the NEI plays an essential role in providing infrastructure and identifying and addressing emerging opportunities.
The planning process must identify the scientific directions for which NEI is well positioned to make major contributions, ensure an inclusive process with grantees and other constituencies having an active role, look inward as well as forward, evaluate NEI operational policies as part of the process, and provide a process for ongoing implementation and evaluation.
Three overarching questions are: Where are we today? Where do we go tomorrow? And how do we get there? The aim is to create a meaningful program planning process to help the NEI identify scientific opportunities, fund the best science, properly direct resources, and attract and train the best and the brightest to vision research
The OPPA Planning Oversight Workgroup was Co-chaired by Charles Gilbert, M.D., Ph.D., Rockefeller University and Richard Stone, M.D., University of Pennsylvania. Members were Drs. Elizabeth Engle, Harvard University, Martin Friedlander, Scripps Research Institute, Michael Gilmore, Schepens, Gordon Legge, University of Minnesota, Todd Margolis, University of California San Francisco, Joram Piatigorsky, NEI, James Rosenbaum, Oregon Health Sciences University, Earl Smith, University of Houston, Lois Smith, Harvard University, Sheila West, Johns Hopkins, and Scott Whitcup, Allergan Inc.
The OPPA Planning Meeting was held at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting on May 2, 2009 to consider NEI Strategic Planning, the role of the National Advisory Eye Council in planning, and extramural programs and operations.
Drs. Gilbert and Stone led an open and informal discussion. The idea is to have a general document as the basic framework, re-visit the objectives, and have a web-based approach to update the document and make modifications. Investigator-initiated research should remain the main focus for the National Eye Institute. The goals could be modified as needed to make decisions about grants and funding.
The OPPA Planning Oversight Workgroup posed the following questions: What are today’s scientific challenges? What are the barriers to progress? What are the scientific, administrative, and resource needs to overcome these barriers? What areas of investigation do not fit into existing program? Should new program areas be developed? Are there opportunities that NEI should address with Funding Opportunity Announcements?
The planning process should have a means of identifying specific opportunities/needs on an ongoing basis. Then the scientific community, as a whole, could comment. This could take place at ARVO or by a similar mechanism that would organize various meetings.
A question arose about using the plan in guiding research and whether or not that was useful. Dr. Sieving replied that the plan is useful as background information and as a roadmap of where you want to go.
Council questioned how they could help in making decisions in prioritizing research, based only on the Plan, without a complete picture of the applications and scores, and knowing what has been funded. Dr. McNicol suggested giving Council a list of the grants that have been funded. Council agreed that this would be helpful.
Drs. Gilbert and Stone posed the following question, “Could the Extramural Research Programs be restructured?” They thought what might best serve the NEI is to add some additional cross-cutting programs. This may require more Program Directors. Areas to consider would include bioengineering, bioinformatics and computational biology, rehabilitation, developmental biology and regenerative medicine.
Spirited discussion ensued about the suggestions and it explored the pros and cons of additional cross cutting programs. Program staff mentioned that a Rehabilitation Program already existed.
A motion was made and seconded to consider additional cross cutting programs in the planning process. A unanimous vote was to accept the motion.
NIH’S ROLE IN THE AMERICAN RECOVERY AND REINVESTMENT ACT (ARRA)
Dr. Loré Anne McNicol, Director, Division of Extramural Research, NEI, discussed ARRA funding at NIH. The purpose of ARRA is to stimulate the economy, create and preserve jobs, and advance biomedical research. he latter has always been the criterion for grant funding. All institutes were given stimulus money in proportion to their share of the NIH budget. NCRR received $1.3B to spend on Extramural infrastructure. Dr. Raynard Kington, Acting NIH Director, has decided to hold half of the stimulus money in the NIH for the new director.
ARRA will stimulate and accelerate biomedical research with existing mechanisms such as funding additional meritorious RO1s, R21s and R03s that have been peer reviewed and approved by IC Councils and with administrative supplements to accelerate ongoing research. It will expand science with new programs such as revisions to existing grants (Competitive supplements), new ARRA NIH-wide programs, and new ARRA IC-specific programs.
NIH received $400M of the $1.1B appropriated for Comparative Effectiveness Research (CER) under the American Recovery and Reinvestment Act of 2009. NIH’s involvement has included participation on the Federal Coordinating Committee (NIH is represented by Dr. Betsy Nabel, Director, NHLBI) charged with working through a common definition on CER. The NIH is participating in the March 2009 Stakeholder meeting of the IOM CER Priority Setting Committee (the priority list is to be issued by June 2009). An NIH CER Coordinating Committee has been created to provide advice to the NIH Director on the best use of the CER stimulus funds, implementation of CER rules and definitions, et cetera. An NIH-Agency for healthcare Research and Quality (AHRQ) CER Subcommittee was created to coordinate the CER dialogue with AHRQ.
Funding has to be approved through various levels, first the IC, then at the NIH Director’s Office, followed by DHHS, and finally at the White House. This is at least a three week process. The NEI has $174M to spend over two years.
Dr. McNicol noted that the additional R01 and R21 grants to be funded have already gone to council. The Competitive Revisions will be coming to Council. The Challenge and AREA grants will be discussed in the September Council round.
A question arose about administrative supplements. Dr. McNicol stated that the NEI anticipated funding at least ¼ to ½ of these supplements.
Another question concerned the administrative supplements for infrastructure. It was answered by noting that the infrastructure initiative was something separate put in place before ARRA using the regular appropriation.
Dr. Sieving adjourned the meeting at 4:15 pm
I hereby certify that, to the best of my knowledge, the foregoing minutes and attachment(s) are accurate and complete.
Dr. Andrew P. Mariani, Ph.D.
National Advisory Eye Council
Division of Extramural Research
National Eye Institute
Paul A. Sieving, M.D., Ph.D.
National Advisory Eye Council
National Eye Institute
These minutes were submitted for the approval of the Council; all corrections or notations were incorporated. A complete, printed copy of the Council minutes, including attachments, may be obtained from:
Ms. Janet L. Craigie
National Eye Institute
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